WOUNDJOURNEY is a longitudinal, real-world observational registry focused on the chronic
disease burden and patient journey of individuals with chronic wounds and ulcers. Data
collection began in 2005 and continues prospectively, capturing structured clinical data
at the point of care using a purpose-built certified EHR or EDC system. These data are
securely transmitted to the U.S. Wound Registry (USWR), a CMS-designated Qualified
Clinical Data Registry (QCDR).
All major wound types are represented: Diabetic foot ulcers (DFUs), diabetic ulcers not
on the foot, Venous leg ulcers (VLUs), Arterial ulcers, Pressure ulcers/injuries,
Surgical complications, Traumatic wounds, Vasculitic/inflammatory, and sickle
cell-related ulcers, and chronic non-pressure ulcers.
The registry collects detailed data on standard-of-care practices and advanced wound care
interventions, including brand-specific information on: Advanced dressings (e.g.,
collagen, antimicrobial), Compression therapy, Offloading devices, Cellular and/or
tissue-based products (CTPs) also called Cellular, Acellular, or Matrix-like Products
(CAMPs) or "skin substitutes," Negative pressure wound therapy, MIST therapy
(low-frequency ultrasound), Topical oxygen therapy (TOT), Hyperbaric Oxygen Therapy
(HBOT), Topical growth factors (e.g., Becaplermin), Enzymatic and mechanical debridement,
Fluorescent imaging for bacterial load, Topical antibiotics and antimicrobials, and other
treatments.
The registry captures key elements of the patient journey, including: Frequency of
debridement, Sites of care, number of patient visits and number of wound visits, Dressing
changes, Use and timing of advanced therapies, Comorbid disease burden and clinical
complexity, Patient Frailty, number of wounds and ulcers per patient, patient time in
service, wound time service, patient and wound outcomes, the development of new wounds
while in service and complication rates.
Wounds are risk stratified using the Wound Healing Index, enabling case-mix adjustment
and longitudinal outcome tracking. Follow-up may extend over five years, capturing
outcomes such as: Complete healing (epithelialization), Non-healing, Major and minor
amputations, Mortality, and Loss to follow-up or transfer of care. Quality of care is
assessed using wound-specific quality measures. The registry integrates real-world
clinical care with research and quality improvement, supporting a learning healthcare
system model.
Through secure tokenization, registry data may be linked to payer claims for
comprehensive longitudinal analysis of healthcare utilization, interventions,
hospitalizations, medication use, and long-term outcomes across care settings. This
enables rigorous, policy-relevant evaluations of standard care and advanced wound
therapies in routine practice. The robust patient and wound level data are suitable to
understand the natural history of chronic wounds and ulcers and to create historical
controls for prospective clinical trials.
